Trial Outcomes & Findings for Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva (NCT NCT01690052)

Last Updated: 2018-06-04

Results Overview

The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record. At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded. The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

4 weeks

Results posted on

2018-06-04

Participant Flow

Patients were recruited from the Salivary Gland Dysfunction Clinic at the U. of K. A cross-over double-blind randomized trial was designed. Two arms were assembled. First arm the SEQUENCE was cevimeline(C) then pilocarpine(P), and for the second the SEQUENCE was P then C. Each participant received the drug for 4 weeks with 1 week washout period.

The total number of patients screened for the study was 28. Of 28 patients, 15 met the inclusion criteria

Participant milestones

Participant milestones
Measure	Cevimeline First, Then Pilocarpine Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.	Pilocarpine First, Then Cevimeline Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
FIRST INTERVENTION: 4 WEEKS STARTED	7	8
FIRST INTERVENTION: 4 WEEKS COMPLETED	6	6
FIRST INTERVENTION: 4 WEEKS NOT COMPLETED	1	2
Washout Period of 1 Week STARTED	6	6
Washout Period of 1 Week COMPLETED	6	6
Washout Period of 1 Week NOT COMPLETED	0	0
SECOND INTERVENTION: 4 WEEKS STARTED	6	6
SECOND INTERVENTION: 4 WEEKS COMPLETED	6	6
SECOND INTERVENTION: 4 WEEKS NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cevimeline First, Then Pilocarpine Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.	Pilocarpine First, Then Cevimeline Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
FIRST INTERVENTION: 4 WEEKS Lost to Follow-up	1	2

Baseline Characteristics

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=15 Participants Two interventions were assembled: For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week. For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Cevimeline n=12 Participants Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.	Pilocarpine n=12 Participants Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
Change From Baseline in Saliva Production in ml. Unstimulated Saliva	1.41 ml Standard Deviation 0.5	3.93 ml Standard Deviation 0.5
Change From Baseline in Saliva Production in ml. Stimulated Saliva	5.31 ml Standard Deviation 0.5	10.34 ml Standard Deviation 0.5

OTHER_PRE_SPECIFIED outcome

Timeframe: four weeks

Adverse events related to the combination and order of study medication will be measured

Outcome measures

Outcome data not reported

Adverse Events

Cevimeline Then Pilocarpine (Intervention 1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pilocarpine Then Cevimeline (Intervention 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Juan F. Yepes DDS, MD, MPH, MS, DrPH, Associate Professor

Indiana University School of Dentistry

Phone: 317-944-9601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place